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Federal Register / Vol. 72, No. 172 / Thursday, September 6, 2007 / Notices
Under § 314.161(a) (21 CFR
314.161(a)), the agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved or (2) whenever a listed drug
NDA No.
is voluntarily withdrawn from sale, and
ANDAs that refer to the listed drug have
been approved. Section 314.161(d)
provides that if FDA determines that a
listed drug was removed from sale for
safety or effectiveness reasons, the
agency will initiate proceedings that
51233
could result in the withdrawal of
approval of the ANDAs that refer to the
listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
Drug
Applicant
9–698
MILTOWN (meprobamate) Tablets, 200 milligrams (mg) and
400 mg
Medpointe Pharmaceuticals, 265 Davidson Ave., Suite 300,
Somerset, NJ 08873–4120
17–481
VERMOX (mebendazole) Chewable Tablets, 100 mg
McNeil Consumer & Specialty Pharmaceuticals, 7050 Camp
Hill Rd., Fort Washington, PA 19034–2999
18–226
BUMEX (bumetanide) Injection, 0.25 mg/milliliter
Roche Laboratories, Inc., 340 Kingsland St., Nutley, NJ
07110–1199
20–463
NASALCROM (cromolyn sodium) Spray, 5.2 mg/spray
Pfizer Consumer Healthcare, 201 Tabor Rd., Morris Plains,
NJ 07950
21–203
TRICOR (fenofibrate) Tablets, 54 mg and 160 mg
Abbott Laboratories, 200 Abbott Park Rd., D–89J45–2, Abbott Park, IL 60064–6133
50–517
MEFOXIN (cefoxitin) for Injection, 10 grams/vial
Merck & Co., Inc., Sumneytown Pike, BLA–20, P.O. Box 4,
West Point, PA 19486
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. Approved
ANDAs that refer to the NDAs listed in
this document are unaffected by the
discontinued marketing of the products
subject to those NDAs. Additional
ANDAs for the products may also be
approved by the agency if they comply
with relevant legal and regulatory
requirements. If FDA determines that
labeling for these drug products should
be revised to meet current standards, the
agency will advise ANDA applicants to
submit such labeling.
Dated: August 29, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–17566 Filed 9–5–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
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Proposed Project: Free Clinic Federal
Tort Claims Act (FTCA) Deeming
Application (OMB No. 0915–0293):
Revision
Under 42 U.S.C. 233(o), and HRSA
BPHC PIN 2004–24, the FTCA Free
Clinic Program requires requesting free
clinics to submit annual, renewal, and
supplemental applications for the
process of deeming qualified volunteer
health care clinicians for FTCA
malpractice insurance coverage. It is
proposed that the FTCA application
forms attached to the current PIN 2004–
24 will be modified in several ways.
These modifications include adding or
clarifying the requirement to include the
following information or data: (1) The
annual number of the free clinic’s
patient visits which are covered by the
FTCA malpractice coverage, (2) a list of
any restrictions, suspensions, or
disciplinary actions related to the
medical licenses of the relevant
volunteer health care clinicians, (3)
clarifying the requirement to include a
copy of the clinic’s IRS 501(c)(3)
documentation, (4) clarifying the need
to detail any medical malpractice claims
filed against any of the relevant
volunteer health care clinicians or
against the clinic for at least the last 10
years, and (5) a clarification of the need
to file future annual renewal
applications by August 1. It is
anticipated that these modifications will
add only incrementally to the time and
effort required by the current OMB
approved FTCA application forms.
The estimated annual burden is as
follows:
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51234
Federal Register / Vol. 72, No. 172 / Thursday, September 6, 2007 / Notices
Number of
respondents
Form
Responses per
respondent
Total
responses
Hours per
response
Total burden
hours
Free Clinic FTCA Application ..........................
150
1
150
16
2,400
Total ...................................................
150
............................
150
............................
2,400
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
Dated: August 29, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review
and Coordination.
[FR Doc. E7–17577 Filed 9–5–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Underage Drinking Prevention:
Town Hall Meeting Feedback Form—
New
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA), Center for Substance Abuse
Prevention (CSAP) is proposing a 2008
Underage Drinking Prevention: Town
Hall Meetings (THM) Initiative. In 2006,
approximately 1,510 THMs were held
by 1,262 community-based
organizations (CBO) throughout the
Nation. Each of the THMs strived to
increase the understanding and
awareness of underage alcohol use and
its consequences by encouraging
individuals, families, and communities
to address the problem. The local THMs
gave communities the opportunity to
come together to learn more about the
new research on underage alcohol use
and its impact on both the individuals
and the community. They also
discussed how their communities can
best prevent underage alcohol use.
To help guide decision making and
planning for future THMs, SAMHSA/
CSAP plans to conduct a process
assessment of the THMs to be held in
2008. CBOs that agree to participate in
this initiative will be asked to provide
feedback about the implementation and
results of the THMs in their community.
This information collection is being
Number of
respondents
Form name
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Feedback Form ................................................................................................
Written comments and
recommendations concerning the
proposed information collection should
be sent by October 9, 2007 to: SAMHSA
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
respondents are encouraged to submit
comments by fax to: 202–395–6974.
Dated: August 29, 2007.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. E7–17581 Filed 9–5–07; 8:45 am]
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implemented under the authority of
Section 501(d) (4) of the Public Health
Service Act (42 U.S.C. 290aa).
The contractor conducting this
information collection will distribute a
brief feedback form to all participating
organizations. The form includes 14
items about the THM, including where,
when, and who conducted the meeting,
number of attendees, format of meeting,
participants in the presentations,
actions planned, media coverage of the
meeting, composition of the audience,
responses of the attendees, materials
provided in the town hall meetings, and
indications of increased awareness and
increased involvement. In addition to
distributing the feedback form, the
contractor will be responsible for
collecting, compiling, analyzing, and
reporting on information requested
through this feedback form.
The feedback form will be completed
by an estimated 1,200 employees from
CBOs. The paper form will take an
average of 10 minutes (.167 hours) to
review instructions, complete the form,
and mail it in a self-addressed, stamped
envelope. This burden estimate is based
on comments from several potential
respondents who reviewed the form and
provided comments on how long it
would take them to complete it.
Responses
per
respondent
1,200
Hours per
response
1
.167
Total hour
burden
200
30-day Notice and request for
comment.
DEPARTMENT OF HOMELAND
SECURITY
ACTION:
[Docket No. DHS–2007–0067]
SUMMARY: The Department of Homeland
Security (DHS) invites interested
persons to comment on the following
forms for the Small Business Innovation
Research (SBIR) program: Company
Registration (DHS FORM 10022),
Research Topic Recommendation (DHS
FORM 10018), Ask a Question (DHS
FORM 10020), Collaboration
Opportunity (DHS FORM 10021),
Reviewer Opportunity (DHS FORM
10019), E-mail Mailing List Signup
(DHS FORM 10016), E-mail Mailing List
Removal (DHS FORM 10024), Proposal
Coversheet (DHS FORM 10017), Cost
Proposal (DHS FORM 10023) forms and
Science and Technology Directorate;
Submission for Review; New
Information Collection Request for
Support of SBIR/STTR Company
Registration Form, Research Topic
Recommendation Form, Ask a
Question Form, Collaboration
Opportunity Form, Reviewer
Opportunity Form, E-mail Mailing List
Signup Form, E-mail Mailing List
Removal Form, Proposal Coversheet
Form, Cost Proposal Form
Science and Technology
Directorate, DHS.
AGENCY:
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Agencies

[Federal Register Volume 72, Number 172 (Thursday, September 6, 2007)]
[Notices]
[Pages 51233-51234]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17577]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, call the HRSA Reports Clearance
Officer on (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (b) the
accuracy of the agency's estimate of the burden of the proposed
collection of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Proposed Project: Free Clinic Federal Tort Claims Act (FTCA) Deeming
Application (OMB No. 0915-0293): Revision
Under 42 U.S.C. 233(o), and HRSA BPHC PIN 2004-24, the FTCA Free
Clinic Program requires requesting free clinics to submit annual,
renewal, and supplemental applications for the process of deeming
qualified volunteer health care clinicians for FTCA malpractice
insurance coverage. It is proposed that the FTCA application forms
attached to the current PIN 2004-24 will be modified in several ways.
These modifications include adding or clarifying the requirement to
include the following information or data: (1) The annual number of the
free clinic's patient visits which are covered by the FTCA malpractice
coverage, (2) a list of any restrictions, suspensions, or disciplinary
actions related to the medical licenses of the relevant volunteer
health care clinicians, (3) clarifying the requirement to include a
copy of the clinic's IRS 501(c)(3) documentation, (4) clarifying the
need to detail any medical malpractice claims filed against any of the
relevant volunteer health care clinicians or against the clinic for at
least the last 10 years, and (5) a clarification of the need to file
future annual renewal applications by August 1. It is anticipated that
these modifications will add only incrementally to the time and effort
required by the current OMB approved FTCA application forms.
The estimated annual burden is as follows:
[[Page 51234]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Total burden
Form respondents respondent Total responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Free Clinic FTCA Application.................................. 150 1 150 16 2,400
-----------------------------------------------------------------------------------------
Total................................................. 150 ................ 150 ................ 2,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857. Written comments should be received within 60 days of this
notice.
Dated: August 29, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review and Coordination.
[FR Doc. E7-17577 Filed 9-5-07; 8:45 am]
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